B
BarryTaylor
As a UK manufacturer, we have been providing orthopaedic implants to the Japanese market for many years. We now understand from our Japanese subsidiary that our UK manufacturing site will be subject to a PAL (periodic?)QMS audit. We have regular NB ISO 13485 audits with minor/no NCs and our last FDA QSR inspection was 483 free.
....However, I am nervous as I do not know what to expect because have no contacts with experience of a Japanese medical devices QMS audit. I can find little on the internet.
It would be great if somebody who has recently experienced could suggest say, their 5 greatest challenges/surprises/opportunities regarding their audit.
Thanks Barry
....However, I am nervous as I do not know what to expect because have no contacts with experience of a Japanese medical devices QMS audit. I can find little on the internet.
It would be great if somebody who has recently experienced could suggest say, their 5 greatest challenges/surprises/opportunities regarding their audit.
Thanks Barry